| CTRI Number |
CTRI/2024/07/070228 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the inhalational anaesthetics and intravenous agents in incidence of emergence agitation,restlessness in surgeries performed in children with less duration |
|
Scientific Title of Study
|
Comparison of the effects of inhalational anaesthetics and total intravenous anaesthesia on the incidence of emergence delirium in paediatric surgeries less than 3 hours duration |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeno Shelton V |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of anesthesiology
Christian medical college
Vellore
Tamilnadu
632004
INDIA
Vellore TAMIL NADU 632004 India |
| Phone |
9095313153 |
| Fax |
|
| Email |
jenoshelton@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ekta Rai |
| Designation |
Professor |
| Affiliation |
Christian medical college Vellore |
| Address |
Department of anesthesiology
Christian Medical College
Vellore
Tamilnadu
India
Vellore TAMIL NADU 632004 India |
| Phone |
9789250113 |
| Fax |
|
| Email |
drektarai@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Ekta Rai |
| Designation |
Professor |
| Affiliation |
Christian medical College Vellore |
| Address |
Department of anesthesiology
Christian Medical College Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9789250113 |
| Fax |
|
| Email |
drektarai@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant
Christian Medical College Vellore 632004 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Jeno Shelton V |
| Address |
Department of anesthesiology
Christian Medical College Vellore 632004
Tamilnadu |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeno shelton V |
Christian Medical College |
Operating room
Department of anaesthesiology
Christian Medical College Vellore
Tamilnadu Vellore TAMIL NADU |
9095313153
jenoshelton@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board and Ethics Committee of CMC Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, (2) ICD-10 Condition: N499||Inflammatory disorder of unspecified male genital organ, (3) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inhalational anaesthetics Isoflurane |
Dose- 1 to 2 percentage with target minimum alveolar concentration MAC of 0.9
Frequency- continuous
Route of administration- inhalataion
Total duration- upto 3 hours till the end of procedure |
| Intervention |
Intravenous anaesthesia with Propofol in maintenance of anaesthesia |
Dose -100 TO 250 microgram per kilogram per hour with target bispectral index 40 to 60
Frequency - continuous infusion
Route of administration - intravenous route
Total duration- upto 3 hours till the end of procedure |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective Genitourinary, Gastrointestinal, Limb surgeries with less than 3 hours duration. ASA physical status I, II |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA physical status III or more
Age less than 2 years and more than 12 years
History of allergic to anaesthetic drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of Emergence Delirium between inhalational and intravenous anaesthestics given as maintenance of anaesthesia using PAED scale |
2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of Nausea and Vomiting among two grups
To compare post operative Analgesia among two groups
To estimate the duration of PACU stay among two groups |
2 hours |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
use of inhalational agents as maintenance is widely practiced in the world.
Meanwhile the use of TIVA is also the best choice in paediatric anaesthesia. So
it is always a debate for inhalational or tiva in management. Emergence
agitation is the important issue in paediatric anaesthesia especially with
inhalational agents. It may precipitate maladaptive behaviour, memory
impairment also.Considering the pharmacological action of propofol, TIVA can be
a good alternative in this. The ideal anaesthetic should be the one with rapid
emergence and short stay in PACU without any side effects. The factors
contributing to emergence delirium are multifactorial including
age,perioperative anxiety,pain,personal character of patient,type of
surgery,rapid awakening, and the anaesthetic agent used4 . Emergence delirium
leads to increased chances of wound dehiscence ,damage to surgical
repair,bleeding,pulling out of drain,iv access , physical self harm to child,
delayed recovery and prolonged hospital stay. This behaviour is often difficult
to manage by the caregivers and needs constant supervision and leads to
parental dissatisfaction 5. Once emergence delirium has occurred ,it increases
the recovery time in PACU,predisposes their parents or caregivers to anxiety
and stress Chandler et al7 showed a lower incidence of ED after total
intravenous anesthesia (TIVA) than that after SEVO anesthesia in children aged
2–6 years following strabismus surgery. Most studies shows the children with
TIVA has shown reduced incidence of emergence agitation when compared to
inhalational agents. In inhalational agent, sevoflurane has higher incidence
than isoflurane. But the role of sevoflurane is needed as it is the induction
agent of choice for pediatrics in whom securing iv line is not possible for
intravenous induction as well as slow and irritant odour inhalataional agent
isoflurane is also not practically used when the child is awake. In our routine
practice in the institution, sevoflurane for induction and isoflurane for
maintenance of anaesthesia is used.So the use of total intravenous anaesthesia
in maintenance is not clearly studied yet in pediatric surgeries. Our study
aims to compare the quality of recovery in terms of incidence of emergence
delirium with the usage of inhalational agent-isoflurane and total intravenous
anaesthesia with propofol in children undergoing surgical procedures with
duration less than 3 hours.
All the children with
ASA 1-2 with age group of 2 to 12 years who are undergoing surgeries –
GI,genitourinary,limb surgeries with duration less than 3 hours will be
recruited. Informed consent who fulfill the inclusion criteria will be obtained
for participation in the study before the procedure. In the operating room
standard ASA(American society of anaesthesiologists) monitors will be
established – Spo2,ECG,NIBP,ETCO2,and bispectral index (BIS)monitor. Sealed
envelopes are used for allocation with two groups. Group A will have isoflurane
as maintenance and group B will have propofol for maintenance of anaesthesia.
This is randomized controlled trial. The investigator will be blinded to the
allocation. Both groups will have endotracheal intubation after administration
with atracurium(0.5 mg/kg) and ventilated with tidal volume of 6-8 ml/kg. The
endtidal carbondioxide is maintained between 30 and 35 by adjusting respiratory
rate and tidal volume.
Group A
(isoflurane group) In inhalational group, Mask induction was performed with
mixture of N2O and O2 for 60 s followed
by incremental increases in inspired sevoflurane. Following loss of
consciousness, an intravenous line was established, fentanyl 0.5 mg/kg is given
and then maintained with inhalational agent- isoflurane with its MAC will be
maintained less than 0.9 .
Group B (TIVA
group) In TIVA group Mask induction was performed with mixture of N2O and O2
for 60 s followed by incremental increases in inspired sevoflurane . Following
loss of consciousness, an intravenous line was established, fentanyl 0.5mg/kg
is given and then maintained with propofol infusion 100 – 250 mcg/kg/hr
administered to achieve appropriate depth of anaesthesia indicated by BIS score
of 40 to 60.
Once all the
procedures were completed, the patients were extubated and transferred to the
postanesthesia care unit (PACU). The data regarding post operative outcomes
will be recorded by the recovery nurse who will be blinded to the anaesthetic
methods. Quality of recovery,postoperative pain, postoperative nausea vomiting,
and extubation time will be taken into record. The extubation time will be
calculated as the time from the end of anesthesia to extubation of the
nasotracheal tube. In the PACU,the time taken till the child shows appropriate
response is noted. Also the patients will be evaluated at10 min intervals using
the Aldrete scale. The Aldrete scoring system is used to clinically evaluate
the physical status of patients recovering from general anesthesia. A score of
0–2 is given for each of the five categories (activity, circulation,
consciousness, O2 saturation, and respiration) with a maximum score of 10.
Recovery time will be calculated from the patient’s arrival to the PACU to the
achievement of an Aldrete score of more than or equal to 9. The Pediatric
Anesthesia Emergence Delirium (PAED) scale will be used to assess patients on
the following five psychometric items: 1. the child makes eye contact with the
caregiver; 2. the child’s actions are purposeful; 3. the child is aware of his
or her surroundings; 4. the child is restless; and 5. the child is
inconsolable. Items 1–3 are reversed scored as follows: 4-not at all; 3-just a
little,2-quite a bit,1-very much,and 0-extremely. Items 4 and 5 are scored as
follows- 0-not at all, 1-just a little,2-quite a bit,3-very much,and 4-extremely.
The scores of each item are summed to obtain a total PAED score.2 ED increases
directly with the total score. A PAED score of more than10 will signify the
presence of emergence delirium. The Face, Legs, Activity, Cry, Consolability
(FLACC) scale will be used to assess the postoperative pain. Responses in each
category will be scored between 0 and 2, for a maximum total score of 10. A pain
score is obtained by reviewing the descriptions of behavior in each of the
FLACC categories and selecting the number that most closely matches the
observed behavior. The numbers obtained for each category are added to obtain
the total pain score, which will be between 0 and 10.10 Observational scoring
was performed immediately after the patient was sufficiently alert to make
purposeful movements. The same blinded nurse will monitor the children for 40
min in the PACU. The PAED and FLACC scores will be evaluated every 10 min
during the observation period, and the highest scores will be recorded for
analysis.
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